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FDA Recommends New Warning for Essure
On October 28, 2016, the U.S. Food and Drug Administration (FDA) announced it is recommending new warnings for labeling for the Essure permanent birth control device. It is also calling for a patient checklist highlighting potential adverse events that have been associated with the device. On November 15, 2016, the new labeling guidelines were finalized.
Essure is considered a means of “permanent” birth control because it is not designed to be removed. It is a small coil made of metal that is inserted into each of a woman’s fallopian tubes. Scar tissue eventually builds up around each coil, making it impossible for sperm to reach a woman’s eggs.
However, the FDA has received many reports of problems associated with the device. These include extreme pain and fallopian tube perforation as well as migration of the device and even expulsion of Essure from the body.
Because of the number of reports the agency received, it convened a meeting of its Medical Devices Advisory Committee in September 2015. This meeting was held in order to hear the opinions of experts and the experiences of patients regarding Essure’s benefits and risks. The FDA also reviewed nearly 3,000 comments it had received on the device.
As a result of the meeting, the FDA decided that women either do not understand the information they receive regarding tubal implants or they are not receiving it. As a result, the agency recommends that Essure labeling should include warnings that spell out the type of adverse events that have been linked to the device. The FDA also recommends that doctors should inform patients of these risks during their consultations.
In addition, the agency recommends that Essure packaging include a checklist that will provide further information to patients. This checklist should be printed out by the patient, who should then review it with her doctor. Once the review is complete, the FDA recommends both the patient and doctor sign it.